Events

Power Load 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Medical Division of Stryker Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    63604
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0566-2013
  • 사례 시작날짜
    2012-10-11
  • 사례 출판 날짜
    2012-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114920
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Stretcher, wheeled - Product Code FPO
  • 원인
    Model 6390 power-load systems built between september 12, 2012 and september 27, 2012 may have been built with a load switch slide that does not meet specifications causing the lifting ability of the arms to be negatively impacted.
  • 조치
    All in process and Load Switch Slides within Stryker control were quarantined on 09/27/2012. Direct accounts were telephoned beginning 10/26/2012 with "Urgent Medical Device Correction" notices sent beginning on 11/30/2012. The notices explained the reason for the recall, hazards involved, and recommended actions. Stryker field service was to contact consignees to schedule replacement of the affected load switch slide. Consignees were asked to forward a copy of his notice to the new users and advise Stryker of their new location. Questions or concerns should be directed to (269) 389-6927 or (269) 389-6954.

Device

Power Load
  • 모델명 / 제조번호(시리얼번호)
    Item 6390000000 Serial Numbers: 120940217 120940257 120940259 120940260 120940261 120940275 120940276 120940277 120940290 120940291 120940292 120940293 120940294 120940431 120940435 120940436 120940437 120940448 120940449 120940454 120940458 120940459 120940203 120940258
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA, Nationwide including the states of PA, NM, MI, IA, CA, CO, WA, VA, IL, WI, NY, WY, MO, TX, and CT.
  • 제품 설명
    The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • 제조사 주소
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA